Pain Clinical Trial
Official title:
A Phase 2b Long-Term, Randomized, Open-Label, Safety And Tolerability Trial Comparing [S,S]-Reboxetine (PNU-165442g) With Routine Care In Patients With Chronic Painful Diabetic Peripheral Neuropathy (DPN).
| Verified date | May 2011 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to assess the long-term safety and tolerability of [S,S]-Reboxetine in patients with chronic painful diabetic peripheral neuropathy
| Status | Terminated |
| Enrollment | 136 |
| Est. completion date | October 2007 |
| Est. primary completion date | October 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Diagnosis of type 1 or 2 diabetes mellitus, with painful, distal, symmetrical, sensorimotor polyneuropathy - Patients at screening must have a score >/=40 mm on the pain visual analogue scale Exclusion Criteria: - Patients with significant hepatic impairment - Patients with other severe pain, that may impair the self-assessment of the pain due to DPN |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Canada | Pfizer Investigational Site | Laval | Quebec |
| Canada | Pfizer Investigational Site | Montreal | Quebec |
| Canada | Pfizer Investigational Site | Ottawa | Ontario |
| Canada | Pfizer Investigational Site | Toronto | Ontario |
| Canada | Pfizer Investigational Site | Toronto | Ontario |
| Canada | Pfizer Investigational Site | Winnipeg | Manitoba |
| Croatia | Pfizer Investigational Site | Osijek | |
| Croatia | Pfizer Investigational Site | Split | |
| Estonia | Pfizer Investigational Site | Pärnu | |
| Estonia | Pfizer Investigational Site | Tallinn | |
| Estonia | Pfizer Investigational Site | Tartu | |
| Estonia | Pfizer Investigational Site | Tartu | |
| Estonia | Pfizer Investigational Site | Viljandi mk. | |
| Finland | Pfizer Investigational Site | Helsinki | |
| Finland | Pfizer Investigational Site | Oulu | |
| Finland | Pfizer Investigational Site | Seinajoki | |
| Finland | Pfizer Investigational Site | Tampere | |
| Germany | Pfizer Investigational Site | Bad Mergentheim | |
| Germany | Pfizer Investigational Site | Mainz | |
| Germany | Pfizer Investigational Site | Meissen | |
| Germany | Pfizer Investigational Site | Muenster | |
| Germany | Pfizer Investigational Site | St.Ingbert | |
| Germany | Pfizer Investigational Site | Tann i.d. Rhoen | |
| Germany | Pfizer Investigational Site | Wuerzburg | |
| India | Pfizer Investigational Site | Ansari Nagar | New Delhi |
| India | Pfizer Investigational Site | Bangalore | Karnataka |
| India | Pfizer Investigational Site | Hyderabad | Andhra Pradesh |
| India | Pfizer Investigational Site | Ludhiana | |
| India | Pfizer Investigational Site | Maharashtra | Mumbai |
| India | Pfizer Investigational Site | Vellore | |
| Poland | Pfizer Investigational Site | Bytom | |
| Poland | Pfizer Investigational Site | Lask | |
| Poland | Pfizer Investigational Site | Lodz | |
| Poland | Pfizer Investigational Site | Lublin | |
| Poland | Pfizer Investigational Site | Otwock | |
| Poland | Pfizer Investigational Site | Wroclaw | |
| Russian Federation | Pfizer Investigational Site | Moscow | |
| Russian Federation | Pfizer Investigational Site | Moscow | |
| Russian Federation | Pfizer Investigational Site | St. Petersburg | |
| Russian Federation | Pfizer Investigational Site | St. Petersburg | |
| South Africa | Pfizer Investigational Site | Durban | Kwa-Zulu Natal |
| South Africa | Pfizer Investigational Site | Durban | Overport |
| South Africa | Pfizer Investigational Site | Durban | |
| South Africa | Pfizer Investigational Site | Durban | |
| South Africa | Pfizer Investigational Site | Houghton, Johannesburg | |
| South Africa | Pfizer Investigational Site | Johannesburg | Gauteng Province |
| South Africa | Pfizer Investigational Site | Parktown | Gauteng Province |
| South Africa | Pfizer Investigational Site | Pretoria | |
| South Africa | Pfizer Investigational Site | Soweto | |
| Sweden | Pfizer Investigational Site | Goteborg | |
| Sweden | Pfizer Investigational Site | Göteborg | |
| Sweden | Pfizer Investigational Site | Göteborg | |
| Sweden | Pfizer Investigational Site | Stockholm | |
| Sweden | Pfizer Investigational Site | Umea | |
| Ukraine | Pfizer Investigational Site | Dnipropetrovsk | |
| Ukraine | Pfizer Investigational Site | Donetsk | |
| Ukraine | Pfizer Investigational Site | Kharkiv | |
| Ukraine | Pfizer Investigational Site | Kyiv | |
| Ukraine | Pfizer Investigational Site | Odessa | |
| United Kingdom | Pfizer Investigational Site | Bath | |
| United Kingdom | Pfizer Investigational Site | Carshalton | Surrey |
| United Kingdom | Pfizer Investigational Site | Dundee | |
| United Kingdom | Pfizer Investigational Site | London | |
| United Kingdom | Pfizer Investigational Site | Manchester | |
| United States | Pfizer Investigational Site | Auburn | California |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Chicago | Illinois |
| United States | Pfizer Investigational Site | Columbia | Missouri |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Greensboro | North Carolina |
| United States | Pfizer Investigational Site | Honululu | Hawaii |
| United States | Pfizer Investigational Site | Huntington Beach | California |
| United States | Pfizer Investigational Site | Jefferson City | Missouri |
| United States | Pfizer Investigational Site | Jonesboro | Arkansas |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Naples | Florida |
| United States | Pfizer Investigational Site | Nashua | New Hampshire |
| United States | Pfizer Investigational Site | Omaha | Nebraska |
| United States | Pfizer Investigational Site | Orangevale | California |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Reno | Nevada |
| United States | Pfizer Investigational Site | Richmond | Virginia |
| United States | Pfizer Investigational Site | Scottsdale | Arizona |
| United States | Pfizer Investigational Site | St Louis | Missouri |
| United States | Pfizer Investigational Site | St. Louis | Missouri |
| United States | Pfizer Investigational Site | Syracuse | New York |
| United States | Pfizer Investigational Site | Tacoma | Washington |
| United States | Pfizer Investigational Site | Winter Park | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Argentina, Canada, Croatia, Estonia, Finland, Germany, India, Poland, Russian Federation, South Africa, Sweden, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Vital signs | duration of study | No | |
| Primary | Physical examination | duration of study | No | |
| Primary | 12-lead ECG | duration of study | No | |
| Primary | Hematology/Biochemistry | duration of study | No | |
| Primary | Adverse events | duration of study | Yes | |
| Secondary | Pain Visual Analogue Scale | duration of study | No | |
| Secondary | Neuropathic Pain Symptom Inventory | duration of study | No | |
| Secondary | Modified Brief Pain Inventory-Short Form | duration of study | No | |
| Secondary | Patient Global Impression of Change | duration of study | No | |
| Secondary | SF-12 Health Survey | duration of study | No | |
| Secondary | EQ-5D | duration of study | No | |
| Secondary | Analgesic Treatment Satisfaction Scale | duration of study | No | |
| Secondary | Pain-related Medication Utilization | duration of study | No |
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